NCT05993559

Necessity of Post-mastectomy Radiotherapy After Neoadjuvant Chemotherapy and Mastectomy

Not yet recruiting Phase 3 Last updated 12 January 2024

What this trial tests

Phase 3 trial testing Arm I (No PMRT) in Breast Cancer in 1,314 participants. Not yet recruiting.

Timeline

11 November 2024

Primary endpoint
10 April 2031

10 July 2031

Quick facts

Lead sponsor	Gangnam Severance Hospital
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,314
Start date	11 November 2024
Primary completion	10 April 2031
Estimated completion	10 July 2031

Drugs / interventions tested

• Arm I (No PMRT)
• Arm II (PMRT)

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Gangnam Severance Hospital

Who can join

20 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Postoperative radiotherapy is generally recommended for patients with breast cancer who have undergone breast-conserving surgery, regardless of prior chemotherapy. However, the criteria for postoperative radiation therapy (PMRT) in patients with breast cancer who have received upfront chemotherapy and mastectomy remain controversial. PMRT is recommended for patients with suspected axillary lymph node metastases before chemotherapy or residual cancer in the axillary lymph nodes after surgery, but this varies by institution and physician. In particular, breast cancer patients with a very good treatment response (pCR or RCB 0-I after prior chemotherapy) have a very good prognosis, and the question of whether PMRT is necessary for these patients continues to be raised. With the addition of new targeted therapies and immuno-oncology agents to conventional chemotherapy, the number of patients with good response is increasing, but there are no prospective studies to date.

The studies that have evaluated the need for PMRT in breast cancer patients with a very good treatment response after upfront chemotherapy and mastectomy are all retrospective studies, lacking evidence to apply to standard of care, and have different definitions of a good treatment response group. Therefore, in this study, the investigators aim to reduce unnecessary overtreatment by comparing survival between PMRT and no PMRT in breast cancer patients with a good response to prior chemotherapy and mastectomy, demonstrating non-inferiority of PMRT to no PMRT. By doing so, the investigators hope to reduce patients' side effects and discomfort, improve their satisfaction and quality of life, and contribute to a new standard of care.

The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of Adjuvant Radiotherapy in the Treatment of Breast Cancer.
   Kolářová I, Melichar B, Sirák I, Vaňásek J, et al · · 2024 · cited 12× · PMID 38534923 · DOI 10.3390/curroncol31030090
2. The Effects of Radiotherapy on the Sequence and Eligibility of Breast Reconstruction: Current Evidence and Controversy.
   Campbell AR, Didier AJ, Sheikh TM, Ansari S, et al · · 2024 · cited 4× · PMID 39272797 · DOI 10.3390/cancers16172939